Electricity-based Mesothelioma Treatment Moves a Step Closer to FDA Approval

Calling it an “extremely promising therapeutic option” that demonstrates “an impressive extension of median overall survival”, researchers testing a new type of pleural mesothelioma treatment announced the final results of their phase II clinical trial this week.

Tumor Treating Fields, a creation of Jersey-based Novocare, are alternating electric fields that destabilize critical proteins, disrupting mesothelioma tumor cell division and killing them.

As Surviving Mesothelioma first reported in April, early tests of the technology looked promising. But the final results of the STELLAR phase 2 mesothelioma clinical trial, released this week, are even better than expected.

Researchers say Tumor Treating Fields may even become part of the new standard of care for pleural mesothelioma.  

Tumor Treating Fields Gain Momentum in Mesothelioma Treatment

Tumor Treating Fields first found success in the treatment of the deadly brain cancer, glioblastoma, the same cancer that recently took the life of Senator John McCain.

In 2016, Novocure turned its attention to the treatment of pleural mesothelioma, another rare cancer that typically carries a poor prognosis.

Based on the preliminary trial results that showed a marked increase in progression-free mesothelioma survival with Tumor Treating Fields, the device received the Humanitarian Use designation from the FDA in 2017.

The final results of the STELLAR trial confirm the value of Tumor Treating Fields, especially in conjunction with chemotherapy, and move the technology a step closer to full FDA approval and availability to more mesothelioma patients.

Pleural Mesothelioma Treatment Extends Survival

In the STELLAR trial, 80 patients with unresectable pleural mesothelioma were treated with both standard chemotherapy (pemetrexed with cisplatin or carboplatin) and Tumor Treating Fields. Their results were compared with historical survival data on pleural mesothelioma patients treated with chemotherapy alone.

Patients who received the combination mesothelioma treatment had a median overall survival of more than a year-and-a-half — a full six months longer than mesothelioma patients treated with chemotherapy alone.

“The final results of the STELLAR trial demonstrate an impressive extension of median overall survival in the treatment of malignant pleural mesothelioma with no increase in systemic toxicity,” said Giovanni Luca Ceresoli, MD, Head of Pulmonary Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy, and an investigator in the trial.

Disease Free Mesothelioma Survival

Mesothelioma patients in the combination therapy group also lived longer free of disease than their chemotherapy-only counterparts.

It took a median of 7.6 months for their mesothelioma tumors to start growing again after treatment, whereas most patients treated only with chemotherapy experience mesothelioma recurrence in about 5.7 months.

“Based on these data, I believe Tumor Treating Fields represent an extremely promising therapeutic option that, if approved, should be added to standard of care chemotherapy for the treatment of malignant pleural mesothelioma,” says Dr. Ceresoli.

Novocure will present the findings to lung cancer experts from around the world at the International Association for the Study of Lung Cancer (IASLC) Conference on Sept. 25, 2018, in Toronto.

Source:

“Tumor Treating Fields Plus Standard of Care Chemotherapy Significantly Extends Median Overall Survival by 6.1 Months in STELLAR Phase 2 Registration Trial in Mesothelioma Compared to Historical Control”, September 5, 2018, Novocure news release